1. Field of the Invention
Unwanted pregnancies and sexually transmitted diseases (STD), including acquired immune deficiency syndrome (AIDS), are now recognized to be world-wide problems needing superior technological, as well as sociological, approaches to control them.
This invention relates to combining a condom and one or more medication-dispensing sponges to increase the efficiency in the prevention of sexually transmitted diseases (or "STD"), as well as unwanted pregnancies, during coitus.
2. Description of Prior Art
Condoms have been used since the 18th century for preventing STD, as well as unwanted pregnancy (see Hatcher, R.A. et al., Contraceptive Technology (1990-1992), Irvington Publishers Inc., NY, 1990). Ninety-nine percent of standard brands of condoms are now made of latex and are supplied with a well for semen at the leading end. Nearly all condoms are approximately 2" wide, 7" long, 0.06-0.08 mm thick, and contain a water-soluble lubricant, such as dry silicone, silicone oil, wet jelly, dry powder or a spermicide. Twelve out of 68 currently produced brands of condoms incorporate .+-.0.5 gm of nonoxynol-9 on the inner and outer surface where the nonoxynol serves as a lubricant, as well as a detergent which reduces surface tension thereby immobilizing and killing sperm, lymphocytes, and microorganisms which cause some STD.
The routine use of condoms, especially those incorporating nonoxynol-9, particularly during nonmonogamous sexual intercourse was recommended in 1990 (See HHS Publication FDA #90-4239). As a barrier contraceptive, as well as a standard means of preventing STD, condoms have many advantages, including general availability, minimal cost per condom, and a high order of effectiveness. The failure to use a condom, or to use a condom properly, has probably been a greater problem than failure on the part of the condom.
U.S. Pat. No. 4,726,359 to Schroeder discloses a removable protective end cap on a condom to aid in orientation of the condom before use. U.S. Pat. No. 4,972,849 to Park et al. describes a sponge molded into the inside (or penile side) of a condom which sponge might serve various purposes, including the prevention of pregnancy or STD, if containing appropriate medications. Park et al. disclose a slot which allows seminal fluid to pass through the condom and out into the vagina as one of Park's embodiments. This embodiment is ineffective in preventing transmission of AIDS and other STD, as well as of questionable effectiveness in preventing pregnancy.
Condoms have recognized failure rates and other disadvantages. The failure of condoms to prevent pregnancy is rated at .+-.12% during the first year of use, compared with 13-18% for vaginal diaphragms and cervical caps, 18-28% for contraceptive sponges, and .+-.21% for spermicides used without adjunctive barriers. The disadvantages of condoms are that: they may break or leak; they may slip off during intercourse or after ejaculation; and they must be taken off immediately after ejaculation before the penis shrinks.
Contraceptive sponges and diaphragms are another popular contraceptive. Natural sea sponges have been used since antiquity for contraception. More recently, open-celled artificial sponges have been used. In 1983, the United States FDA (Food and Drug Administration) approved polyurethane open-cell vaginal contraceptive sponges for use in the United States. The most common form on the market, the TODAY Vaginal Contraceptive Sponge, is a 1.75".times.5" pillow-shaped polyurethane sponge that contains 1 gm of nonoxynol-9 spermicide. It has a concave dimple on one side intended to fit over the cervix of the female uterus which decrease the chance of dislodgement during intercourse. The other side of the sponge incorporates a woven polyester loop to facilitate removal of the sponge. The sponge is available in one size, over-the-counter, without prescription. It is moistened with tap water prior to use and inserted deep into the vagina with the concave dimple over the cervix. Once in place, the sponge provides continuous contraceptive protection for up to 24 hours. After use, it is discarded. Its contraceptive effect is exerted by releasing nonoxynol-9 within the sponge, by providing a barrier in front of the cervix, and by trapping sperm within the sponge.
U.S. Pat. No. 4,393,871 to Vorhauer describes a 1 1/2 inch diameter, nonoxynol-impregnated "Diaphragm-Disk" with an adhesive coat on one side to line the inside of a diaphragm. U.S. Pat. Nos. 4,332,243 and 4,446,860 to Gutnick describe a burstable medication-releasing well in the wall of a diaphragm or a condom. Gutnick's device depends on the rupture of a partitioning membrane in the wall to release medicament.
Sponges have both advantages and disadvantages to their use. Advantages of contraceptive sponges are that they are easy to buy and use; they can be expected to release increased quantities of water-soluble nonoxynol-9 where most needed in conjunction with intravaginal pressure changes which take place during penile thrusts; they may remain in the vagina after and through more than one episode of coitus; they offer some degree of protection against STD, especially gonorrhea and chlamydia infections; and theoretically offer some protection against other infections, such as genital herpes, trichomonas, syphilis and AIDS. The detergent effect of water-soluble compounds, such as nonoxynol-9, released from the compressed sponges reduces surface tension to the point that motile sperm, lymphocytes, and microorganisms cannot migrate effectively in semen or endocervical secretions.
There are two major disadvantages of contraceptive sponges. They do not necessarily stay where intended, owing to the fact that they have no secure means of retention in front of the cervix of the female uterus. Actually, they are prone to dislocate and rotate, such that they become very difficult for some women to retrieve. Secondly, they are prone to cause endocervical or vaginal irritation, and often foul odor, especially if left in too long. (In addition, the sponge is a relatively expensive form of contraception.)
Thus, although there exist forms of contraceptive devices, i.e. condoms, sponges and diaphragms, which have distinct advantages as both contraceptive and STD prevention methods, these devices also have distinct disadvantages. The devices may either fail to prevent conception, ineffectively prevent STD, and worse, such failures may discourage people from using these important health-protection devices.